Ignite Creation Date:
2024-05-06 @ 6:03 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05521880
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2022-08-22
Brief Title:
Anchoring Sequential Intermittent Long Acting Antimicrobials With Medication for Opioid Use Disorder MOUD for Invasive Infections Related to Opioid Use
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Anchoring Intermittent Long Acting Antimicrobials to Medication for Opioid Use Disorder Treatment to Facilitate Structured Transitions of Care for People Who Use Drugs Admitted to the Hospital With Invasive Infections
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AIM-STOP
Brief Summary:
Standard of care for patients with opioid use disorder and complicated infections is discharge to subacute nursing facilities on IV antibiotics until completion of treatment course We aim to determine the efficacy of an alternative strategy using intermittent outpatient oritavancin therapy dosed weekly combined with initiation and continuation of medication assisted treatment for opioid use disorder for completion of antimicrobial therapy in a 12 week prospective open-label study Patients hospitalized for a drug use related infection and thought to need prolonged parenteral antimicrobial therapy will be assessed by a substance use consultant and Infectious Diseases service If they are not on Medication for Opioid Use Disorder MOUD they will be assessed for initiation of MOUD A collaborative multidisciplinary discharge planning process will be initiated and will involve linkage to care If they have an infection with a gram positive organism and are thought to be clinically stable for hospital discharge they will be assessed for appropriateness for oritavancin and first dose will be administered prior to discharge They will have an intake into an opioid treatment program where they can access collocated services and will be discharged with linkage to care through a peer recovery coach They will be assessed in this collocated clinic post discharge for optimization of MOUD and progress of infection and subsequent doses of oritavancin will be administered Patients will be followed for 12 weeks for curecompletion of therapy and MOUD outcomes
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None